| Primary | Percentage of Participants With Booster Response in Terms of Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titer Levels at 1 Month After Booster Vaccination | Serogroups included: Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). The rSBA titer levels greater than or equal to (>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer >=1:8. Data reported below is including both seropositive and seronegative participants. | Booster according-to-protocol(ATP)Cohort for immunogenicity: met booster ATP cohort for safety, comply procedures in protocol, meeting visit interval from primary vaccination(vac) in 109069 to booster vac,blood sampling intervals, had assay results with no vac before post booster vac blood draw. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
| | | Title | Denominators | Categories |
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| rSBA-MenA | | | Title | Measurements |
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| - OG00081.5(74.6 to 87.1)
- OG00184.3(71.4 to 93.0)
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| | rSBA-MenC | | |
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| Secondary | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069(NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Before booster vaccination, 1 month after booster vaccination (Vac) | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | rSBA Geometric Mean Titers for Each of the 4 Serogroups Before Booster Vaccination and 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units. | Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Before booster vaccination, 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Percentage of Participants With Anti-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL Before Booster Vaccination and 1 Month After Booster Vaccination | Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized. | Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Before booster vaccination, 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Geometric Mean Concentrations (GMCs) of Anti-Tetanus Toxoid Before Booster Vaccination and 1 Month After Booster Vaccination | TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. The GMCs calculations was performed by taking the anti-log of the mean of the log concentration transformations. Antibody (Anti-TT) concentrations below the cut-off value (0.1 IU/mL) of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation. | Booster ATP Cohort for immunogenicity: met requirements of booster ATP cohort for safety, comply procedures in protocol included meeting visit interval from primary vaccination in 109069 (NCT00464815) to booster vaccination and blood sampling intervals, had assay results with no vaccine administered before post booster vaccination blood draw. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Before booster vaccination, 1 month after booster vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Percentage of Participants With Solicited Local and General Adverse Events Within 4 Days After Booster Vaccination | Solicited local reactions included pain, redness and swelling. Pain graded as: (0= none, 1= mild, not interfered/prevented normal activity, 2= moderate, painful when limb moved/interfered with normal activity, 3= severe, significant pain at rest/ prevented normal activity). Redness and swelling scored as:0= None, 1= 0 to less than or equal to (<=) 20 millimeter (mm), 2= greater than (>) 20 to <=50 mm, 3=>50 mm. Solicited general reactions: headache, fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea /abdominal pain) graded as (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe / prevented normal activity). Fever categorized as: 0= less than (<) 37.5 degree Celsius (C), 1= >=37.5 to <=38.5 degree C, 2= >38.5 to <=39.5 degree C, and 3= >39.5 degree C. | Booster total vaccinated cohort (TVC) for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants evaluable for this measure. | Posted | | Number | | percentage of participants | | Within 4 days post booster vaccination (Day 0 to Day 3) | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Percentage of Participants With Unsolicited Adverse Events (AEs) Within 31 Days After Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. And any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. | Booster TVC for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 31 days after booster vaccination (Day 0 to Day 30) | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs), Guillain-Barre Syndrome (GBS) and New Onset of Chronic Illnesses (NOCI) Within 31 Days After Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. GBS is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently. All occurrences of GBS has to be reported as an SAE. New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. | Booster TVC for safety included all vaccinated participants in study 109069 (NCT00464815) with a MenACWY-TT booster vaccine administration documented in study MENACWY-TT-101. | Posted | | Number | | percentage of participants | | Within 31 days after booster vaccination (Day 0 to Day 30) | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Secondary | Percentage of Participants With SAEs Related to Primary Vaccination and Any Events Related to Lack of Vaccine Efficacy After 10 Years of Primary Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Occurrence of SAEs related to primary vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the participant's last visit in the primary study 109069 (NCT00464815) or in persistence study 112148 (NCT00974363); extension study: 109069 (NCT00464815) at Year 2, 3, 4, 5 after primary vaccination until entry in study MenACWYTT-101, which is extension of study 109069 (NCT00464815), 10 years post primary vaccination. | The total cohort at Month 120 (10 years post primary vaccination) included all vaccinated participants from the vaccination of Study 109069 (NCT00464815) who return for the Month 120 follow-up. | Posted | | Number | | percentage of participants | | 10 years after primary vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Other Pre-specified | Percentage of Participants With rSBA Titer Levels >=1:8 and >=1:128 For Each of the 4 Serogroups at 10 Years After Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | ATP Cohort for Persistence at Month 120: participants who eligible in Study 109069 (NCT00464815), received primary vaccination with MenACWY-TT or Mencevax ACWY during Study 109069, had assay results for at least one tested antigen at Month 120, did not received a meningococcal vaccine not planned in Study 109069 before Month 120 visit. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 10 years after primary vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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| Other Pre-specified | Geometric Mean Titers With rSBA For Each of the 4 Serogroups at 10 Years After Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers were expressed as the reciprocal of the highest serum last dilution resulting in at least 50% reduction of meningococcal colony-forming units. | ATP Cohort for Persistence at Month 120: participants who eligible in Study 109069 (NCT00464815), received primary vaccination with MenACWY-TT or Mencevax ACWY during Study 109069, had assay results for at least one tested antigen at Month 120, did not received a meningococcal vaccine not planned in Study 109069 before Month 120 visit. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | 10 years after primary vaccination | | | | ID | Title | Description |
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| OG000 | ACWY-TT Group | Participants received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. | | OG001 | MenPS Group | Participants received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly as primary vaccination in study 109069 (NCT00464815) and then 10 years post primary vaccination received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly as booster vaccination. Participants were also evaluated for long-term persistence (of immune response and safety) at year 10 post primary vaccination. |
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